BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 1IN

    MDR report key: 12380630 · Received August 27, 2021

    Report

    Report Number
    3002682307-2021-00447
    Event Type
    Malfunction
    Date Received
    August 27, 2021
    Date of Event
    June 17, 2021
    Report Date
    November 3, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 9/8/2021. H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 200224. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TEN NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE SAMPLES WERE EXAMINED; HOWEVER, NO SIGNS OF DEFECT COULD BE IDENTIFIED. BASED ON THE PROVIDED INFORMATION AND THE SAMPLE ANALYSIS RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 VIALS OF MEDICATION HAD FOREIGN PARTICLES/FIBERS IN THEM AFTER BEING DRAWN UP BY THE NEEDLES 25GA 1IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER PRODUCTION THEY HAVE FOUND SMALL, HARDLY VISIBLY PARTICLES/FIBERS IN THE MEDICATION AND THEY WANT TO INVESTIGATE IF THE PARTICLES ORIGINATE FROM THE BD PRODUCTS."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 100 VIALS OF MEDICATION HAD FOREIGN PARTICLES/FIBERS IN THEM AFTER BEING DRAWN UP BY THE NEEDLES 25GA 1IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AFTER PRODUCTION THEY HAVE FOUND SMALL, HARDLY VISIBLY PARTICLES/FIBERS IN THE MEDICATION AND THEY WANT TO INVESTIGATE IF THE PARTICLES ORIGINATE FROM THE BD PRODUCTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276695 NEEDLE 25GA 1IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 200224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown